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Table 2 Calculation formulas and detection standards of signal mining

From: Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System

Method

Computational formula

Threshold value

ROR

\(\:\text{R}\text{O}\text{R}=\frac{(a/c)}{(b/d)}=\frac{ad}{bc}\)

\(\:95\text{\%}\text{C}\text{I}={\text{e}}^{\text{l}\text{n}\left(\text{R}\text{O}\text{R}\right)\pm\:1.96\sqrt{\:\:(\frac{1}{\text{a}}+\frac{1}{\text{b}}+\frac{1}{\text{c}}+\frac{1}{\text{d}})\:\:}}\)

ROR025 > 1, N ≥ 3

PRR

\(\:\text{P}\text{R}\text{R}\,=\,\frac{a/(a+b)}{c/(c+d)}\)

\(\:{\upchi}2=\frac{\:{(\text{a}\text{d}-\text{b}\text{c})}^{2}(\text{a}+\text{b}+\text{c}+\text{d})}{(\:\text{a}+\text{b})(\text{a}+\text{c})(\text{c}+\text{d})(\text{b}+\text{d})}\)

PRR ≥ 2, \(\:{\upchi}2\ge\:\)4, N≥3

BCPNN

\(\text{IC}\,=\,{log}_{2}\frac{p(x,y)}{p\left(x\right)p\left(y\right)}={log}_{2}\frac{a(a+b+c+d)}{(a+b)(a+c)}\)

\(\:\text{I}\text{C}025={\text{e}}^{\text{l}\text{n}\left(\text{I}\text{C}\right)\pm\:1.96\sqrt{\:\:(\frac{1}{\text{a}}+\frac{1}{\text{b}}+\frac{1}{\text{c}}+\frac{1}{\text{d}})\:\:}}\)

IC025 > 0

MGPS

\(\:\text{E}\text{B}\text{G}\text{M}\,=\,\frac{a(a+b+c+d)}{(a+c)(a+b)}\)

\(\:\text{E}\text{B}\text{G}\text{M}05={\text{e}}^{\text{l}\text{n}\left(\text{E}\text{B}\text{G}\text{M}\right)\pm\:1.96\sqrt{\:\:(\frac{1}{\text{a}}+\frac{1}{\text{b}}+\frac{1}{\text{c}}+\frac{1}{\text{d}})\:\:}}\)

EBGM05 > 2